Deputy QPPV Senior Principal Professional – LEO Pharma – Ballerup

Your role Your primary task will be to act as an EU and UK  QPPV when delegated by the QPPV. The deputy QPPV has ultimate accountability for the development, oversight and improvement of the structure and processes of the LEO Pharma global PV system to ensure regulatory compliance for all medicinal products for which LEO Pharma holds marketing authorizations. •    To establish and maintain the LEO Pharma global PV system, including establishment and maintenance of the Pharmacovigilance System Master File (PSMF) •    To maintain an overview of the safety profile, and any emerging safety concerns of marketed products•    Review of QMS and documents related to delegated LEO medicinal products•    Support to audits and inspections•    Guide and support colleagues the global PV organization including experienced PV professionals and managers•    Lead and support improvement and compliance initiatives•    Act as process owner for PV intelligence  •    Act as the GS Data Protection Focal Point (DPFP) Your qualifications  To succeed in this role, we imagine that you have the following qualifications:•    MD, Pharmacist, or other relevant master’s degree in health science•    6-10 years of solid PV experience•    Solid pharmacovigilance knowledge and able to apply this knowledge and solve problems in new areas in a risk-based manner •    Ability to significantly influence and lead functional initiatives with an organization-wide impact •    Be involved in several projects, deal with multiple priorities and impact decisions significantly •    Train and develop other experienced PV professionals across teams in the pharmacovigilance discipline •    Communicate critical and/or complex results, ideas, or visions to Senior leadership level and/or to strategic LEO partners •    Global Perspective: Strategic thinker, challenge status quo & lead change – capability to push boundaries to execute innovative quality & compliance methods & systems •    Problem solving & trouble shooting – ability to analyze & resolve issues & make sound judgments balancing business & compliance requirements•    Strong relationship builder – ability to work with PV partners across global boundaries e.g. affiliates and pers in industry •    Good IT skills and experienced user of common Microsoft Office programs •    Proficient in verbal and written English  Your new team The QPPV Office Team is part of Global Safety and is comprised of 8 dedicated and passionate professionals based at LEO´s headquarter in Ballerup. We strive to efficiently communicate and manage risks throughout the life cycle of our products to ensure an optimal benefit/risk profile of all LEO Pharma products.  We are driven by a high level of professionalism, integrity, respect for each other and an open-minded approach contributing to an inspiring and fun working environment together with our colleagues.

Read more…